How to achieve good results with the GORE® VIABAHN® Endoprosthesis for treating complex
femoropopliteal occlusive disease: Results from the Japanese IDE trial
National Principal Investigator:
Takao Ohki, MD, PhD
Jikei University, Tokyo, Japan
Disclosure
Speaker name: Takao Ohki
.................................................................................
I have the following potential conflicts of interest to report:
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
GORE® VIABAHN® Endoprosthesis with PROPATEN BioactiveSurface
Ultra-thin wall ePTFE tube
Unique, durable bonding film
Polished nitinol support
Contoured proximal edge
Lengths: 2.5, 5, 7.5, 10, 15, 25 cm
Diameters: 5–13 mm
CBAS Heparin Surface*
* PROPATEN Bioactive Surface is synonymous with the CBAS Heparin
Surface.
Achilles' heel of FP bypass (PTFE): Thrombosis
CBAS technology
3 years post implant
Propaten
Control PTFE
Compliant with the Mechanical Forces of the SFA
• More than 700,000 GORE® VIABAHN®
Endoprosthesis sold worldwide
• Very low incidence of reported fractures(< 0.015%)
• Capable of longitudinal compression with little residual force
• Superb flexibility
Mechanical Forces in the SFAFlexion
Flexion“The curvature of the femoral vessels was studied and quantified in stretched and flexed positions…Three or more small curves were seen proximal to the knee joint in all volunteers”1
1 Wensing PJ, Scholten FG, Buijs PC, Hartkamp MJ, Mali WP, Hillen B. Arterial tortuosity in the femoropopliteal region during knee
flexion: a magnetic resonance angiographic study. Journal of Anatomy 1995;187(Pt 1):133-139.
Mechanical Forces in the SFALongitudinal Compression
Longitudinal Compression“From the supine position to the fetal position, the SFA shortened 13% ± 11% (P < .001)”1
The GORE® VIABAHN®
Endoprosthesis is capable of longitudinal compression with little residual force
1 Cheng CP, Wilson NW, Hallett RL, Herfkens RJ, Taylor CA. In Vivo MR Angiographic Quantification of
axial and twisting deformations of the superficial femoral artery resulting from maximum hip and knee
flexion. Journal of Vascular & Interventional Radiology 2006;17(6):979-987.
#1 Achilles' heel of SFA stenting: ISR
Blocking Neointimal Hyperplasia
• Achilles' heel of SFA stenting Mechanical Barrier
Stent Graft(VIABAHN)
• Original stimulus for stenosisremoved from the equation
• Pore size provides a barrier to tissue ingrowth
Difference between BMS ISR (diffuse, usually symptomatic) and covered stent edge stenosis (focal and often asymptomatic)
If stenosis does recur, have changed an initial TASC II C or D lesion to TASC A
Tough restenosis
Ideal SFA stent
- Mechanical barrier against intimal hyperplasia
- Fracture resistant
- Thrombosis resistant
Viabahn: 5.0-250mm
Edge stenosis
Typical Viabahn restenosis
Only at the edge
PSVR:2.4
Re-intervention easily performed with
Viabahn 5.0mm x 2.5cm
The evolution of a device
Heparin-coated, contoured edge, low profile (0.018” compatible) device used in the Japan IDE Trial.
Japan VIABAHN® IDE Trial:Basic strategy of the trial
• No interventional treatment was approved for lesions greater than 15cm in length in Japan
• Significant number of FP bypass was done for TASC II C/D lesions at the start of the trial
• A device that was proven in long, complex lesions was needed• Invasiveness measures devised to prove lower invasiveness of
VIABAHN compared to FP bypass: if equal performance percutaneous wins
• Repeat percutaneous procedures under local anesthesia for ISR not considered as a defeat
• Avoidance of bypass surgery and maintenance of flow important• Led to Primary Assisted Patency =avoidance of surgery as primary
endpoint
For the purpose of IDE approval the downside or FP bypass was exaggerated
Wound infection following FP bypass
Gore Japan IDE Clinical Study:Performance in Patients that may Otherwise Require Bypass
Gore Japan IDE Clinical Study: Performance in patients who may otherwise require bypass
Follow-up:• 1, 3, 6, 12 and 24 month CDUS
• Annual visits through 5 years to assess
fracture, AE’s
• Primary patency data available through 24
months
• fTLR data will be collected through 60
months
Outcome depends on what you treat:Where Viabahn Japan data fits
* Prospective Randomized or Prospective Multicenter (> 2 sites) SFA studies included. Studies that did not report primary patency at 12-months are not included. Patency
definitions may vary: where Kaplan-Meier estimates with a PSVR of ≥ 2.5 are available, these were used for comparison. For the GORE® VIABAHN® Endoprosthesis, only
studies that utilized the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface were included. Drug-coated balloon studies were only included for those studies
that report data for devices currently approved in the US. Atherectomy: non-SFA lesions were included in the reported patency rates in the CELLO (N = 5 out of 65 total)
and Pathway PVD trials (N = 76 out of 210 total). Non-SFA lesions were included in the reported patency rates in the Micari, et al. study (N = 12 out of 114 lesions total),
LEVANT I Trial (N = 4 out of 49 total), LEVANT II Trial (N = 31 out of 316 total), and IN.PACT SFA I and II Trial (15 out of 221 total).1-29
** Gore RELINE clinical study was for treatment of in-stent restenosis in the SFA.27
★
Proper Sizing Correlates with Optimal OutcomesSize was not measured but eyeballed in the Viper Trial
IVUS seldom used
* Gore VIPER Clinical Study: A prospective, multi-center study of 119 limbs in the U.S. (19 cm average lesion length). Overall results 73% Primary Patency. Retrospective
analysis was done on device sizing by Core Lab on 95 limbs. For devices oversized < 20% at the proximal edge Primary Patency was 88%.1
** GORE® VIABAHN® Endoprosthesis Japan IDE Clinical Study demonstrated 12-month primary patency of 92% as defined by evidence of flow with no target lesion
revascularization (TLR). The same study demonstrated 88% 12-month primary patency when defined by PSVR of < 2.5 without TLR.
Inclusion / Exclusion Criteria Designed to Target Complex SFA Disease
• Inclusion Criteria
—Rutherford 2–5
—ABI ≤ 0.9 or TBI ≤ 0.5
—Surgical bypass candidate
—Angiographic:
• Lesion length ≥ 10 cm (No upper limit)
• SFA lesion
– 1 cm below the SFA origin and ending 1
cm above the intercondylar notch
• Patent distal popliteal artery
• At least one patent tibial artery
• Lesion can be pre-dilated
• Reference vessel diameters between 4.0
and 7.5 mm. Must be measured and not
estimated
• IVUS encouraged
• Exclusion Criteria
—Untreated flow-limiting aortoiliac
disease (could be treated during index
procedure)
—Any previous stenting or surgery
in target vessel
—Femoropopliteal aneurysm
—Rutherford 5 with active infection
—Known coagulation disorder
—Current dialysis
—Contraindication to
anticoagulation or antiplatelet
Anatomical inclusion criteria
Proximal medial condyle
Proximal landing zone >1cmProfunda
SFA
Popliteal
1cm
1cm
Inclusion criteria•Lesion length >10cm•No upper limit•Rutherford category 2-5•Reference vessel diameter 4 to 7.5 mm
Majority of Patients Were Older Men with a History of Smoking and Diabetes
Evaluated in Long, Complex Lesions Generally indicated for Bypass
Population enrolled generally suitable for bypass: Mean lesion length 22cm and 84.5% TASC II C or D
Device Evaluated in a Challenging Biomechanical Environment
With over half the patients reporting sitting seiza-style or cross-legged at least 25% of the time, this population presents a challenging biomechanical environment for long lesions that were allowed to extend through Hunter’s canal to 1 cm above the intercondylar notch.
Seiza style
Stent-Grafts Were Less Invasive than Bypass
Treatment with stent-grafts shown to be less invasive than bypass by all measures
* Retrospective series of 68 bypass patients collected from study sites (6 / 15 sites). Patient selection
was done according to a similar set of inclusion / exclusion criteria as those treated by the study
device.
Primary effectiveness endpoint met
91 / 100 patients at the end of one year follow-up were occlusion free
94.1% Primary Assisted Patency K-M at day 365
Statistically non-inferior to 80% PP of surgical bypass from literature
88% Primary Patency in 21.8 cm Average Length Lesions
• In the Gore Japan IDE Clinical Study, the GORE® VIABAHN® Endoprosthesis demonstrated 88% 12-month primary patency*
• Average Lesion Length 21.8 cm
* GORE® VIABAHN® Endoprosthesis Japan IDE Clinical Study demonstrated 12-month primary patency of 92% as
defined by evidence of flow with no target lesion revascularization (TLR). The same study demonstrated 88% 12-
month primary patency when defined by PSVR of < 2.5 without TLR.
Subgroup analyses93% Primary Patency in Lesions Between 10–20 cm
• In the Gore Japan IDE Clinical Study, the GORE® VIABAHN® Endoprosthesis demonstrated 92.7% 12-month primary patency in lesions between 10 and 20 cm*
• Average Lesion Length 16.2 cm
* GORE® VIABAHN® Endoprosthesis Japan IDE Clinical Study demonstrated 100% 12-month primary patency as defined by evidence of flow with no target lesion
revascularization (TLR) in lesions ≤ 20 cm and ≥ 10 cm (shortest length allowed for enrollment). Average lesion length 16.2 cm. N = 43 of 103. The same study
demonstrated primary patency of 92.7% when calculated using PSVR of < 2.5 with no TLR in lesions ≤ 20 cm and ≥ 10 cm (shortest length allowed for enrollment).
Subgroup analyses85% Primary Patency in Lesions > 20 cm
• In the Gore Japan IDE Clinical Study, the GORE® VIABAHN® Endoprosthesis demonstrated 84.8% 12-month primary patency in lesions greater than 20 cm*
• Average lesion length: 25.7 cm
* GORE® VIABAHN® Endoprosthesis Japan IDE Clinical Study demonstrated 86.5% 12-month primary patency as defined by evidence of flow with no target lesion
revascularization (TLR) in lesions > 20 cm. Average lesion length 25.7 cm. N = 60 of 103. The same study demonstrated primary patency of 84.8% when calculated using
PSVR of < 2.5 with no TLR in lesions > 20 cm.
Several Key Patient Factors Showed No Impact to Primary Patency
No significant differences in patency
• Diabetes
• Lesion calcification
• Subject age
• Number of runoff vessels
• Smoking status
• Hypertension
PTA dilation
6 x 15cm
VIABAHN®
Merit and demerit of Covering Collaterals
Covering Collaterals
Complete lesion coverage / Increased flow through device
PreserveCollaterals
Minimize failureLess risk of limb threat?
Competing interests
-Complete coverage prevents progression
-Prevents competing flowCollaterals provide a flow path in case of device failure
Safety endpointNo Acute Limb Ischemia, No Fractures, No Bypass
•No cases of Acute Limb Ischemia (ALI) were
observed through end of 12 month follow-up
*Occlusions : 6
• No fractures were identified by core laboratory
• No patient required bypass
• Limb salvage 100%
• No patient death, target vessel revascularization, or major
amputation within 30 days
Proper Sizing Correlates with Optimal OutcomesSize was not measured but eyeballed in the Viper Trial
IVUS seldom used
* Gore VIPER Clinical Study: A prospective, multi-center study of 119 limbs in the U.S. (19 cm average lesion length). Overall results 73% Primary Patency. Retrospective
analysis was done on device sizing by Core Lab on 95 limbs. For devices oversized < 20% at the proximal edge Primary Patency was 88%.1
** GORE® VIABAHN® Endoprosthesis Japan IDE Clinical Study demonstrated 12-month primary patency of 92% as defined by evidence of flow with no target lesion
revascularization (TLR). The same study demonstrated 88% 12-month primary patency when defined by PSVR of < 2.5 without TLR.
Unlike the Viper trial size was measured in the Japan Trial
* Gore VIPER Clinical Study: A prospective, multi-center study of 119 limbs in the U.S. (19 cm average lesion length). Overall results 73% Primary Patency. Retrospective
analysis was done on device sizing by Core Lab on 95 limbs. For devices oversized < 20% at the proximal edge Primary Patency was 88%.1
** GORE® VIABAHN® Endoprosthesis Japan IDE Clinical Study demonstrated 12-month primary patency of 92% as defined by evidence of flow with no target lesion
revascularization (TLR). The same study demonstrated 88% 12-month primary patency when defined by PSVR of < 2.5 without TLR.
Proper sizing is critical to achieving successful outcomes.1, 5
Unlike the Viper trial size was measured in the Japan Trial
* Gore VIPER Clinical Study: A prospective, multi-center study of 119 limbs in the U.S. (19 cm average lesion length). Overall results 73% Primary Patency. Retrospective
analysis was done on device sizing by Core Lab on 95 limbs. For devices oversized < 20% at the proximal edge Primary Patency was 88%.1
** GORE® VIABAHN® Endoprosthesis Japan IDE Clinical Study demonstrated 12-month primary patency of 92% as defined by evidence of flow with no target lesion
revascularization (TLR). The same study demonstrated 88% 12-month primary patency when defined by PSVR of < 2.5 without TLR.
Proper sizing is critical to achieving successful outcomes.1, 5
How to achieve good results with the GORE® VIABAHN® Endoprosthesis: Lessons from the Japan trial
Best practices followed throughout the study
•Vessel size at landing zones was required to be measured, not estimated
—Quantitative angiography was used in all cases
—IVUS was used in 70%
—Device sizes were chosen per IFU (5 – 20% oversizing)
•Landing zones were carefully selected so that all disease was covered
•Pre and post-dilation performed in all cases (high pressure balloons in most)
•Dual antiplatelets were required for six months and recommended for 12
months
—Aspirin and clopidogrel (or other theopyridine class)
—Cilastozol additionally prescribed in some cases
•Consistent follow-up was performed
—1, 3, 6, and 12 month duplex ultrasound
A BFigure 1
* *
VIABAHN Japan IDE Example
3 yrs post stent
A
B
C
ABI unchanged at 0.9
pre post pre post
Viabahn
Rt SFA treated with Viabahn Lt SFA with BMS
BMS
2Yrs 6Month
Japan Viabahn Case with internal controlCourtesy of Dr Yamaoka
• Despite including mostly TASC II C/D lesions (84.5%), the GORE® VIABAHN® Endoprosthesis showed 88% Primary Patency and 94% Primary Assisted Patency
• These are lesions normally recommended for treatment by above knee bypass
• The GORE® VIABAHN® Endoprosthesis has the potential to replace bypass for treatment of long/complex lesions
• In medium length lesions ≤ 20cm, Primary Patency was 93%
• Other interventional devices have mainly been studied in shorter lesions
• Stent-grafts may be preferred to other interventional treatments in medium length lesions
• With no cases of ALI, and no patients requiring bypass or amputation, safety has been shown
• The Japanese IDE Trial results are a result of careful technique
• Quantitative sizing
• Complete disease coverage
• Diligent post PTA
• Dual antiplatelet administration
• Good follow-up
Japan Viabahn Trial: Summary
Evolution of a device, evolution of techniques,
accumulation of data
Heparin-coated, contoured edge, low profile (0.018” compatible) device
used in the Japan IDE Trial.
Japan IDE approval
2 Year Results
Will be presented in Main Arena Room 1 at 17:14 in the session titled “New concepts for
complex femoropopliteal disease”.
Eluvia stent (Majestic trial)
R 2-4 n=57
Mean Lesion length 7.1 cm
Primary patency 1 yr 96% 2 yr 78.2%
Hulsbeck SM LINC 2017
1yr success does not guarantee 2yr so stay tuned
Japan Viabahn conducted with Ideal SFA stent, Ideal practice
- Mechanical barrier against intimal hyperplasia
- Fracture resistant
- Thrombosis resistant
- Contour edge
- Viabahn implant tricks
- <20% oversizing
- Full lesion coverage
- DAPT, Diligent FU
Proven Patency for Complex SFA Lesions
• 88% 12-month primary patency
• Good technique drives great outcomes
— Proper sizing is critical
• 93% Primary Patency in lesions between 10–20 cm (average 16.2 cm)
• Zero cases of ALI, bypass, or amputation
References
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femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the
Treatment of Superficial Femoral Artery Obstructive Disease) Trial. Journal of Vascular & Interventional Radiology
2013;24(2):165-173.
2. Lammer J, Zeller T, Hausegger KA, et al. Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery
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3. Zeller T, Peeters P, Bosiers M, et al. Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the
Viabahn-25 cm Trial. Journal of Endovascular Therapy 2014;21(6):765-774.
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Conference (NCVH); June 5-7, 2013; New Orleans, LA.
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References
How to achieve good results with the GORE® VIABAHN® Endoprosthesis for treating complex
femoropopliteal occlusive disease: Results from the Japanese IDE trial
National Principal Investigator:
Takao Ohki, MD, PhD
Jikei University, Tokyo, Japan